Plasma-derived medicines policies
Each plasma-derived medicine is unique, due to the pharmacological and manufacturing differences across different brands and to each patient’s unique response to the treatments. These therapies are non-interchangeable, sole-source biologics, therefore it is essential that patients have continued access to their specific therapy. One-size-fits-all policies are not suitable for plasma-derived medicines and endanger patient health.
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UK Department of Health
“Although the active ingredient in IVIg — purified immunoglobulin — is the same from brand to brand, there are considerable differences in the manufacturing processes used. This results in individual products that cannot be used interchangeably.”
Clinical Guidelines for Immunoglobulin Use; the UK Department of Health, 2008, p. 15
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UK Department of Health
“Although the active ingredient in IVIg — purified immunoglobulin — is the same from brand to brand, there are considerable differences in the manufacturing processes used. This results in individual products that cannot be used interchangeably.”
Clinical Guidelines for Immunoglobulin Use; the UK Department of Health, 2008, p. 15
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Plasma-derived medicines policies
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IPOPI – International Patient Organization for Primary Immunodeficiencies
“It is important to realize that there is no single immunoglobulin (Ig) product or method of administration that is suitable for all PID patients. [...] All countries and immunodeficiency centres should have access to a wide spectrum of Ig products, to provide optimal treatment for all immunodeficient patients.”
Frontiers in IMMUNOLOGY, Primary Immune Deficiencies – Principles of care; Hypothesis and Theory Article, published: 15 December 2014, doi: 10.3389/fimmu.2014.00627
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IPOPI – International Patient Organization for Primary Immunodeficiencies
“It is important to realize that there is no single immunoglobulin (Ig) product or method of administration that is suitable for all PID patients. [...] All countries and immunodeficiency centres should have access to a wide spectrum of Ig products, to provide optimal treatment for all immunodeficient patients.”
Frontiers in IMMUNOLOGY, Primary Immune Deficiencies – Principles of care; Hypothesis and Theory Article, published: 15 December 2014, doi: 10.3389/fimmu.2014.00627
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Plasma-derived medicines policies
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Iris – Association des patients déficit immunitaires primitifs, France
“Immunoglobulins are not interchangeable with each other, they are not generic medicines, prescribers must have long-lasting and readily available preparations.”
Immuno-déficience primitive, Recherche, Information, Soutien (I.R.I.S.) Position Statement Summary
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Iris – Association des patients déficit immunitaires primitifs, France
“Immunoglobulins are not interchangeable with each other, they are not generic medicines, prescribers must have long-lasting and readily available preparations.”
Immuno-déficience primitive, Recherche, Information, Soutien (I.R.I.S.) Position Statement Summary
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Plasma-derived medicines policies
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Council of Europe
“[...] Take into account that human normal immunoglobulin therapeutic products differ from one another in terms of production processes, which might have an impact on specificationsand clinical performance.”
Council of Europe, Resolution CM/Res(2015)2 on principles concerning human normal immunoglobulin therapies for immunodeficiency and other diseases (Adopted by the Committee of Ministers on 15 April 2015 at the 1225th meeting of the Ministers’ Deputies)
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Council of Europe
“[...] Take into account that human normal immunoglobulin therapeutic products differ from one another in terms of production processes, which might have an impact on specificationsand clinical performance.”
Council of Europe, Resolution CM/Res(2015)2 on principles concerning human normal immunoglobulin therapies for immunodeficiency and other diseases (Adopted by the Committee of Ministers on 15 April 2015 at the 1225th meeting of the Ministers’ Deputies)
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Plasma-derived medicines policies
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